Urology Specialist Group Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Urology Specialist Group LLC from 02/27/2026 to 03/03/2026. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6076 493.1441 Condition: Laboratory Director D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on record review and staff interview, the Laboratory Director (LD) failed to provides overall management and direction by ensuring the laboratory enrolled in a CMS-approved Proficiency Testing (PT) program for Bacteriology and Mycology specialties while the laboratory did Patient testing in 2025. Refer to D6088. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the testing performed and that-- This STANDARD is not met as evidenced by: Based on records review and staff interview, the Laboratory Director (LD) failed to ensure the laboratory enrolled in Proficiency Testing (PT) for the second event of 2025 when the laboratory tested 150 patients using Realtime Polymerase Chain reaction (PCR) test to detect bacteria and or fungal presence in urine samples. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Findings included: 1-Review performance evaluation signed by the LD on 03/04 /2025, revealed that the laboratory approved a test using a Realtime Polymerase Chain reaction (PCR) test for the detection of the following microorganisms in urine samples: Acinetobacter Baumannii, Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida Lusitanae, Candida tropicalis, Citrobacter freundii, Enterobacter aerogenes, Enterococcus faecalis, Enterococcus faecium, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morgamii, Mycoplasma hominis, Proteus Mirabilis, Proteus vulgaris, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Staphylococcus saprophyticus, Streptococcus agalactiae, Ureaplasma uralyticum, and the following gen resistance: tampc, CTX-M group1, CTX-M group 2, ErmA, ErmB, FemA, KPC, mecA, mefA, NDM, OVA-48, QNr A, QnrB, SHV, TEM, vanA1/2, vanB, VIM/IMP- 7. 2- Record review of the laboratory American of Proficiency Institute (API) PT records for 2025, revealed that the laboratory had no records for 2025 1st and 2nd event and that the laboratory failed to do an external verification of the testing method or a split sample for the period of reference. 3-Patient records review revealed that the laboratory tested 150 patient samples from 05/29/2025 to 08/22/2025. 4- During an interview on 02/27/2026 at 2:15 PM the General Supervisor confirmed that LD failed to ensure the laboratory participated in Proficiency Testing in 2nd event of 2025 or participated in an alternative evaluation. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A complaint survey for 2021001268 was conducted on 3/03/2021-3/10/2021 at Urology Specialist Group LLC. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to create a general quality assurance (QA) policy for the laboratory regarding Polymerase chain reaction (PCR) testing with Quant studio 3. Findings Included: Review of QuantStudio 3 instrument folder displayed the validation of the instrument was completed on 2/25/2021. Review of QuantStudio 3 manual revealed no documentation of a QA policy onsite. During an interview on 3/9/2021 at 3:11pm, the office manager confirmed there was no QA policy for the PCR testing with QuantStudio 3. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have the current Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory director (LD) sign the procedure manual to approve the use since their hire date on 1/15/2021. Findings Included: A review of CMS-116 revealed LD#B as the current LD. Review of Hiring Emails revealed LD#B started as LD on 1/15/2021. Review of Procedure Manual revealed no documentation of an approval signature by LD#B in the procedure manual. During an interview on 3/9/2021 at 3:11 pm , the office manager confirmed LD#B had not signed the procedure manual for use as of 1 /15/2021. -- 2 of 2 --